Quality Control Management

Neelesh Laxmikant Khadke

Mobile: 940-***-****, P hone: 024*-*******

Email: *****************@**********.***

PROFESSIONAL PROFILE

CORE COMPETENCIES

- Implementation of SAP

for Management of

Stability studies,Cotrol

Samples,Column &

Chemical Management,

- Preventive maintenance and

Calibration through SAP.

- Water Quality Monitoring

through SAP

- E-log books through Calibre-

Lims

- Analytical techniques

MANAGEMENT SKILLS

- Excellence in Analytical &

SAP related Problem solving

- Analytical investigation

- Strong Influencing Skills

- Achievement oriented

Team Builder

- Influential Communicator

A dynamic professional with around 13.5 years of rich experience

in Pharmaceuticals Quality Control Department.

Currently working with Lupin Ltd. Aurangabad manufacturer of

Tablets, capsules & liquid products.

Strategist with proven abilities in era of Quality control department.

Proven track record of successfully superseding predefined

targets and accomplishing consistent growth.

Highly successful in building relations with decision makers;

seizing control of critical problem areas and delivering on time.

Skills in communication, presentation with demonstrated abilities

in mentoring motivated teams towards achieving organizational

goals.

EXPERTISE ORBIT

- SAP system - New Initiatives / Set-ups - ANDA documentation

- Management of Raw Materials - Training & Development - People Management

ORGAN ISATIONAL EXPERIENCE

Lupin Ltd. Aurangabad as a Sr. Executive April-2005 - to Till Date

RESPONSIBILITIES:

Planning & control for Raw material samples .

Preparation & `execution of SAP & Clibre Lims Quality Projects

To look after Sampling, allocation and releases of Raw material samples

Compilation & review of all analytical reports against specification & maintenance for the

same.

Maintenance of HPLC columns.

Updating of SAP,Master data.

Preparation & updation of Inspection plan in SAP for Raw material Specifications.

Preparation of e-TDS for analytical test recording.

Responsible for investigation of Out of specification results.

Responsible for Control sample updation of Raw materials.

Responsible for Submission of Raw materials data for ANDA & commercial product to

regulatory authority as per commitment.

Responsible for query response to regulatory authority.

Responsible for c-GMP compliance.

Preparation & execution of Standard operating procedures, Change Control & Deviation for

laboratory control.

Laboratory compliance and training personals

Control samples/Reference samples management.

.

Aurobindo Pharmaceuticals Ltd. Hyderabad As a Jr. Officer April 2004- to April-2005

RESPONSIBILITIES:

Analysis of Raw materials. .

Analysis of Process validation samples for US commercial Products.

Analysis of Finished Products.

Preparation of volumetric solution, standard solution and reagent used in raw material

analysis and its documentation.

Preparation and compilation of Validation Protocols.

Cleaning validation.

Ajanta Pharmaceuticals Ltd. Paithan As a Officer November 2000- to March-2004

RESPONSIBILITIES:

Analysis of Raw materials. .

Analysis of Finished Products.

In process quality control ( IPQC ) in Production and Warehouse area.

Loan license Auditing as a Quality Control Representative.

Instrument Handling: -

pH and conductivity meter:- (Make:- Mettler Toledo, Orion)

HPLC `(Shimadzu, Agilent, Dionex Chromoleon software)

KF titratior:- ( Make:- Mettler Toledo,Metrohm )

Potentiometer:- ( Make:- Mettler Toledo )

Spectrophotometer:- ( Make:- Shimadzu, Jasco )

Refractometer:- ( Make:- Abbey )

Polarimeter. – ( Rudolph, Jasco )

Infrared Spectroscopy: ( Make:- Shimadzu )

Dissolution Tester ( Electrolab, Lab India )

Friability tester ( Electrolab )

Disintegration Tester ( Electrolab )

Documentation activities: -

Preparation of SOP’s.

Preparation of Analytical specification, standard test procedure, COA.,

Preparation of various records of Quality control department.

Preparation of Stability protocols, reports. Planner.

Preparation of OOS protocols & Reports.

Audits Faced:-

USFDA, WHO, ANVISA, TGA, MCC

ACADEMIA

Master of Science

Dr. B.A.M. University Aurangabad

Maulana Azad College, Aurangabad ( State- Maharashtra )

Diploma in GMP

Insights professional management, Pune.

Bachelors of Science

Dr.Babasaheb Ambedkar Marathwada University

Badrinarayan Barwale college, Jalna ( State- Maharashtra )

Higher Secondary Certificate Examination

Maharashtra State Board, Aurangabad

COMPUTER PROFICIENCY

MS Office –Having fluency in Word, Excel & Power Point.

Internet Access & E-mail operations.

Working on System Applications & Products in data processing (SAP)

Working on E-Logbook System though Calibre Lims.

PERSONAL PROFILE

Date of Birth : 14 June 1976

Address : Tirupati Supreme Enclave, Flat No. M/A-2, Near Railway station

Flyover, Jalan Nagar Aurangabad.

Marital Status : Married.

Languages Known : Marathi, Hindi and English.

DATE:-

PLACE: - (Neelesh Laxmikant Khadke)

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